[Ip-health] ​Notes from today’s hearing on the KEI v NIH lawsuit over the Gilead CAR T patent license

James Love james.love at keionline.org
Mon Oct 15 13:59:51 PDT 2018

I thought things went well in court today, but nothing was decided, yet
(which itself was some good news, since the NIH had a motion to dismiss).



Notes from today’s hearing on the KEI v NIH lawsuit over the Gilead CAR T
patent license
October 15, 2018

Today (Monday October 15, 2018), Judge Peter J. Messitte of the United
States District Court, District of Maryland, convened a hearing on a motion
by the NIH to dismiss a lawsuit (Case 8:18-cv-01130-PJM) by KEI regarding
the decision by the NIH to grant an exclusive license on CD30 protean CAR T
patents to Gilead Sciences (via the Kite Pharma subsidiary). The various
pleadings in the case are available here:

The NIH had decided that KEI did not have the right to an administrative
appeal of the NIH decision to grant the patent licenses to Gilead, and had
asked the judge to dismiss our lawsuit on the the grounds that KEI lacked
standing to sue the NIH over the license to Gilead.

The KEI lawsuit seeks to establish KEI’s right to have the NIH consider our
appeal (it was denied before it was even filed), as well as to determine if
the NIH was subject to 40 USC § 559, which provides that an “executive
agency shall not dispose of property to a private interest until the agency
has received the advice of the Attorney General on whether the disposal to
a private interest would tend to create or maintain a situation
inconsistent with antitrust law.”

The hearing has held by Judge Peter J. Messitte. Judge Messitte spent
considerable time questioning the Department of Justice lawyer regarding
its objections to our standing, but also on the NIH’s own process for
administrative appeals, which are not set out by regulation.

The NIH failed to have our suit dismissed, at least for now, and Judge
Messittee ordered briefing on the following question(s):

(1) as a matter of administrative law (i.e. court decisions reviewing
actions by government agencies in general, not just the statutes and
regulations directly applicable to NIH), was KEI entitled to a hearing on
either or both (a) its objections to the NIH’s decision to issue the
license and (b) the NIH’s refusal to consider KEI’s appeal; and,

(2) if not, does that procedure violate KEI’s constitutional right to due

James Love.  Knowledge Ecology International

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